Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

This study aims to verify the results from our previous retrospective cohort analysis by establishing a database of well-characterised patients prospectively. The different prevalence of neurological disorders, abdominal, urological and obstetrical surgery, diarrhoea and other potential associated factors as well as the importance of abnormalities identified by 3D high resolution anorectal manometry (HARM) will be compared between subjects with feacal incontinence (FI), double incontinence (DI) and controls. Presence and severity of both FI and urinary incontinence (UI) will be evaluated by disease specific questionnaires. Measuring both disease severity and Quality of Life (QoL) is needed to determine the true impact of incontinence. Finally, the impact on quality of life will be compared between both groups.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age > 18 years;

Self-reported faecal incontinence.

Disqualifiers

Impossibility to perform the anorectal manometry because of pain, stenosis or organic disease;

Active (peri)rectal inflammation, including abscess;

Pregnancy;

Inability to cooperate during the anorectal manometry

Trial population

All patients referred for HARM for FI are eligible to enroll in the database.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    Disease specific questionnaires

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Double incontinence1 intervention
Group B: faecal incontinence1 intervention
Group C: controls1 intervention

Trial outcomes

Primary outcomes

1

compose a database of patients suffering from faecal or double incontinence

a database will be created

Time frame
during inclusion visit

Secondary outcomes

1

Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

this outcome will be assessed using jorge and wexner score

Time frame
during inclusion visit
2

Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

this outcome will be assessed using vaizey score

Time frame
during inclusion visit
3

Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

this outcome will be assessed using International consultation on incontinence questionnaire

Time frame
during inclusion visit
4

Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence

this outcome will be assessed using clinical frailty score

Time frame
during inclusion visit

Other outcomes

Sponsors and contacts

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